Safety Requirements
■ Categorization
− Type of protection against electric shock: Class I
− Degree of protection against electric shock (when the patient is in physical contact):
Type BF or type CF applied part
− Degree of protection against the ingress of harmful liquids: General equipment
− Degree of safety of use in the presence of flammable anesthetic agent mixed with air,
oxygen, or nitrous oxide: Not suitable for use near flammable anesthetic agent mixed
with air, oxygen, or nitrous oxide
− Mode of operation: Continuous operation
■ Safety standards the device conforms to
− Medical electrical equipment, part 1: General requirements for basic safety and
essential performance IEC 60601-1:2005/A1:2012
− Medical electrical equipment, part 1-2: General requirements for basic safety and
essential performance - Collateral standards: Electromagnetic compatibility -
Requirements and tests IEC 60601-1-2:2007
− Medical electrical equipment, part 1-6: General requirements for basic safety and
essential performance - Collateral standards: Usability IEC 60601-1-6:2010
− Medical electrical equipment, part 2-37: Particular requirements for the basic safety and
essential performance of ultrasonic medical diagnostic and monitoring equipment IEC
60601-2-37:2007
− Medical electrical equipment, part 1: General requirements for safety IEC 60601-1:1988,
A1:1991, A2:1995
− Medical electrical equipment, part 1-1: General requirements for safety - Collateral
standards: General requirements for medical electrical systems IEC 60601-1-1:2000
− Medical electrical equipment, part 1-2: General requirements for safety - Collateral
standards: Electromagnetic compatibility - Requirements and tests IEC 60601-1-2:2001,
A1:2004
− Medical electrical equipment, part 1-4: General requirements for safety - Collateral
standards: Programmable electrical medical systems IEC 60601-1-4:1996, A1:1999
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